QA Specialist — Flow Cytometry & GxP Compliance

Discovery Life Sciences; Huntsville (AL); Hybrid; USD 70,000 - 85,000; Full time

Benefits offered by this job

Dental & Vision

Life Insurance

Disability Coverage

401(k) Match

Paid Time Off

Professional Development

Employee Referral Program

Job summary

Discovery Life Sciences seeks a Quality Assurance Specialist to support quality/compliance across our Specialty Lab Services, including Flow Cytometry, Genomics, and Proteomics. You will assist with audits, supplier qualifications, change management, and CSV, ensuring adherence to GxP and 21 CFR Part 11.

The role requires a life sciences degree, 5+ years QA experience in regulated settings, and knowledge of ICH-GCP. Hybrid work in Huntsville, AL, with travel as needed.

Qualifications

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Minimum 5 years of Quality Assurance experience in regulated scientific environments.
• Familiarity with Flow Cytometry in CAP/CLIA settings and understanding of ICH-GCP requirements.
• Strong knowledge of Quality Management Systems (QMS) and regulatory standards (FDA, ICH, MDR, IVDR, CAP/CLIA, GCP, GCLP, ISO 13485).
• Experience with audits (internal, supplier, external) and CAPA management.

Responsibilities

• Maintain, monitor, and support adherence to the Quality Management System (QMS) across Discovery's Specialty Lab Services operations.
• Ensure compliance with applicable regulations and internal quality procedures (GCP, GCLP, CAP/CLIA, ISO 13485, ISO 15189).
• Provide quality guidance and training on documentation practices, quality standards, and compliance expectations.
• Serve as the primary QA partner for Flow Cytometry operations and collaborate with lab SMEs to embed quality requirements.
• Lead and support external audits and internal audits; drive audit readiness and issue resolution.
• Facilitate investigations, CAPA, deviations, and continuous improvement using root-cause analysis.
• Oversee Change Management and CSV activities to ensure 21 CFR Part 11 and GxP compliance.
• Manage US supplier qualification activities and conduct supplier audits.

Education

Bachelor's degree in Life Sciences

Certified Quality Auditor (CQA) or comparable quality certification

Job description

Discovery Life Sciences seeks a Quality Assurance Specialist to support quality/compliance across our Specialty Lab Services, including Flow Cytometry, Genomics, and Proteomics. You will assist with audits, supplier qualifications, change management, and CSV, ensuring adherence to GxP and 21 CFR Part 11.

The role requires a life sciences degree, 5+ years QA experience in regulated settings, and knowledge of ICH-GCP. Hybrid work in Huntsville, AL, with travel as needed.